Posted: 2 March 2026
Peter MacCallum Cancer Centre has treated the milestone first patient in a first-in-human Phase I clinical trial assessing PMCC-COE19, an experimental CAR T-cell therapy fully developed by Peter Mac and manufactured onsite by Cell Therapies.
The PLATYPS trial brings together the drug development and clinical expertise of Peter Mac and the highly specialised manufacturing capabilities of Cell Therapies, which is co-located in the same building.
This Phase I trial is assessing PMCC-COE19 in eligible patients with CD19-expressing blood cancers, including diffuse large B-cell lymphoma and B-cell acute lymphoblastic leukaemia. Enrolled patients are no longer responding to standard treatments and are not eligible for other CAR T-cell therapies. Each patient will receive a single infusion of PMCC-COE19 and will be monitored over time to assess response and side-effects. The first of 12 patients has been infused, and preparations are underway to treat the second patient imminently.
Peter Mac’s Centre of Excellence in Cellular Immunotherapy has advanced PMCC-COE19 from laboratory bench to patient bedside, including product manufacture and Therapeutics Goods Administration (TGA) approval to proceed to evaluation in a clinical trial.
“For over a decade, Peter Mac has led the way in both the clinical application and regional manufacture of CAR T-cell therapy – a groundbreaking treatment that can save the lives of patients with aggressive blood cancers,” said Professor Simon Harrison, Director of the Centre of Excellence in Cellular Immunotherapy. “We are now proud to reach this critical milestone of treating the first patient with PMCC-COE19 – our own CAR T-cell therapy – and which, through the GMP (Good Manufacturing Practice) capabilities and highest quality standards of our manufacturing partners at Cell Therapies, can be manufactured within our building.
“This milestone reflects the dedication and collaboration of an extraordinary team both at Peter Mac and Cell Therapies, and whose efforts are bringing us closer to offering this, and other innovative cellular immunotherapies, to more patients in need.”
Cell Therapies is Australia’s largest GMP-licensed manufacturing facility focused exclusively on cell therapies, and the clinical doses of PMCC-COE19 are being manufactured within its specialised clean lab facilities co-located in the same building as Peter Mac.
Cell Therapies CEO Dr Bev Menner said: “Our team is delighted to see the initiation of this first clinical trial based on an in-house product from the Centre of Excellence in Cellular Immunotherapy, a novel IP accelerator platform.
“Together, we are bringing research, clinical, and manufacturing expertise into one partnership to drive the translation and commercialisation of innovative Australian IP to the clinic, enabling patient access to therapies that have the potential to be truly game-changing.”
CAR T-cell therapy involves collecting T-cells from a patient’s blood and modifying these cells to recognise the patient’s cancer. The CAR T-cells are then infused into the patient, where they attack cancer cells, multiply and expand, and can provide ongoing protection by living in the patient’s blood.
Several CAR T-cell therapy products are approved for use in Australian patients against certain blood cancers. However, PMCC-COE19 represents an advance as the product has been developed and manufactured by an Australian team to provide an alternative option for patients.
Haematologist Dr Katherine Cummins will oversee the PLATYPS trial as principal investigator.
PMCC-COE19 is the second in a pipeline of CAR T-cell therapies to be fully developed and manufactured under one roof in Australia. Several other new CAR T-cell therapies are in development by Peter Mac, including novel CAR T-cells for a range of both blood and solid organ cancers. This is being led by the Centre’s Chief Scientist, Professor Jane Oliaro, and Manufacturing and Development Manager, Dr Jessica Li. It is hoped these CAR T-cell products will also soon receive approval from the TGA, allowing more clinical trials to open later in 2026 and beyond.
